Understanding FDA Regulations and Role in Opioid Pain Management

Why Should You Attend:

FDA recently issued a final guidance to help industry develop opioid drug products with potentially abuse-deterrent properties. Opioids, as powerful medications, can help manage pain when prescribed and used properly. However, when opioids are used improperly or for recreational purposes, they can cause serious harm, including overdose and death.

It is important for the industry to accurately understand FDA roles and applicable regulation governing controlled substances to adequately achieve compliance. This webinar will help industry get better familiar with FDA regulations and its role including recent opioid drug approvals with abuse-deterrent properties concerning chronic pain management.

At the end of the webinar, attendees will be better aware of FDA regulations, its role, and recent approvals involved in chronic pain management: opioid medications with abuse-deterrent properties.

Learning Objectives:

• To better understand opioid regulations in the US
• To accurately understand FDA’s role in governing controlled substances

Areas Covered in the Webinar:

• Laws and Regulations
• Definitions
• FDA Regulations
• Controlled Substances
• Regulatory Requirements for Good Clinical Practice (GCP)
• FDA Regulatory Requirements for Abuse-Deterrent Opioid Medications
• FDA Regulation and Approval for Opioid Medications
• Opioid Misuse and Abuse
• Prevention of Opioid Abuse
• Recent FDA Approvals for Opioid Medications
• Appropriate Pain Management
• Best Practices

Who Will Benefit:

• Global pharmaceutical industry professionals
• Compounding pharmacy professionals
• Pharmaceutical industry professionals
• Healthcare industry management
• Healthcare industry professionals
• Controlled substance and pain management industry staff
• Opioid users, caregivers and pain management professionals

Instructor Profile:

Dr. David Lim, Ph.D., RAC, ASQ-CQA, is president and principal of Regulatory Doctor. He frequently presents global regulatory and quality compliance topics at various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, he developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. He leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. He also serves as a member of the Advisory Board for Inspection Insider published by FDA News.

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